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Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis

NCT03684187 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-25

No results posted yet for this study

Summary

To assess the efficacy of mindfulness-based intervention (MBI) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).

Conditions

Interventions

BEHAVIORAL

Mindfulness Based Intervention

Mindfulness - Based Intervention (MBI) Course: The 8-week MBI program is comprised of an orientation session, 8 separate weekly sessions of 2.5 hours and also a 7.5 hour retreat session on a weekend day. The orientation session will include an introductory session, description of the course and will include completion of stress surveys. During the orientation session, there will be explanation to the patients of objectively the basis of mindfulness teaching. The role of the stress surveys that are conducted are to assess an individual's degree of stress prior to the initiation of any mindfulness practice teaching. Subjects will also be asked to wear a BodyGuard 2 (BG2) for parts of the study, on average of 7 days at baseline, end of the control phase, end of intervention phase, and end of 48 week follow up period. This will track subjects heart rate (HR), HR variability, VO2, energy expenditure and activity.

Sponsors & Collaborators

  • American Liver Foundation

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Marina Silveira, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2019-06-26
Completion
2023-04-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684187 on ClinicalTrials.gov